Study type

Study type

Non-interventional study

Scope of the study

Disease epidemiology
Non-interventional study

Non-interventional study design

Cross-sectional
Study drug and medical condition

Medical condition to be studied

Asthma
Population studied

Age groups

  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)

Estimated number of subjects

3404
Study design details

Main study objective

The main objective is to describe patients aged 18 years or older with GINA 4/5 asthma, enrolled in ISAR, by OCS use and biomarker distribution, Type 2 characteristics and individual biomarkers, prior to biologic initiation. An added objective is to describe those patients with low eosinophilic phenotypes and who have long-term OCS use prior to biologic initiation.

Outcomes

Demographic and clinical characteristics will be described for GINA Steps 4/5 patients with no, intermittent and long-term OCS use. The prevalence of type 2 characteristics, as defined by biomarkers or concomitant type 2 disease, will also be presented. Demographic and clinical characteristics will be described for GINA Steps 4/5 patients with low eosinophilic phenotypes (blood eosinophils <150 cells/microL) and long-term OCS use.

Data analysis plan

The final sample size will depend on the number of individuals with available data on biomarkers, OCS use and type 2 comorbidities. Analysis will be undertaken in STATA and R. As the study requires descriptive analyses, no inferential statistics will be performed. Continuous variables will be summarised using means, standard deviations, medians and interquartile ranges. Categorical variables will be shown as number and percentage.